Concizumab-mtci (By injection)

Concizumab-mtci (kon-SIZ-ue-mab - mtci)

Prevents and decreases the frequency of bleeding in patients with hemophilia A or hemophilia B.

Brand Name(s):

Alhemo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually injected into the thigh or stomach.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, red, bruised, or hard, or into areas with moles, scars, or stretch marks.
• You may use the prefilled pen from the refrigerator or allow it to warm to room temperature before using it or warm the pen in the palm of your hands. Do not warm it by using a heat source.
• Check the liquid in the pen. It should be clear and colorless to slightly yellow. It may have particles that you can see-through or are white. Do not use it if it is discolored, frozen, bent, or damaged.
• 60 mg/1.5 mL prefilled pen:
  • Wash your hands with soap and water before and after using this medicine.
  • Push the needle straight onto the pen. Turn the needle clockwise until it is on tight. Pull off the outer and inner needle cap.
  • Prime the pen. Select 0.4 mg when turning the dose selector. Hold the pen with needle pointing up. Press the dose button until it stops. You should see the medicine at the needle tip. If you do not see the medicine, repeat the priming steps up to 6 times. If there is still no medicine, do not use the pen.
  • Turn the dose selector to select your prescribed dose. Insert the needle straight into your skin at a 90 degree angle. Press and hold the dose button down until you see a "0" in the dose counter. Slowly count to 6 while the needle is still in your skin. Remove the needle from your skin. You will hear or feel a click when the dose counter returns to "0".
  • Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Recap the pen and store it without a needle attached.
• 150 mg/1.5 mL and 300 mg/3 mL prefilled pen:
  • Wash your hands with soap and water before and after using this medicine.
  • Push the needle straight onto the pen. Turn the needle clockwise until it is on tight. Pull off the outer and inner needle cap.
  • Prime the pen. Select 1 mg when turning the dose selector. Hold the pen with needle pointing up. Press the dose button until it stops. You should see the medicine at the needle tip. If you do not see the medicine, repeat the priming steps up to 6 times. If there is still no medicine, do not use the pen.
  • Turn the dose selector to select your prescribed dose. Insert the needle straight into your skin at a 90 degree angle. Press and hold the dose button down until you see a "0" in the dose counter. Slowly count to 6 while the needle is still in your skin. Remove the needle from your skin. You will hear or feel a click when the dose counter returns to "0".
  • Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Recap the pen and store it without a needle attached.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
  • Starting dose (first 4 weeks of treatment): If you miss a dose, call your doctor or pharmacist for instructions.
  • Maintenance dose:
    • For 1 missed dose: Use it as soon as possible.
    • For 2 to 6 missed doses: Inject 2 doses as soon as possible and go back to your regular dosing schedule.
    • For 7 or more missed doses: Call your doctor or pharmacist for instructions.
• If you store this medicine at home, keep it in the refrigerator. Do not freeze. Protect the medicine from direct light. Keep the medicine in the original package until you are ready to use it. You may store the opened prefilled pen at room temperature for up to 28 days. Throw away opened pen after 28 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment and for 7 weeks after the last dose.
• Tell your doctor if you are breastfeeding, or if you have blood clots.
• This medicine may increase your risk for blood clots.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, coughing up blood
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, redness, swelling, or a lump under your skin where the shot is given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 3/4/2025